FDA UDI
In Commercial Distribution
🇺🇸 United States
CURVTEK EYE NEEDLE
DI: 00880304408241
·
Model: 906768
·
Biomet Orthopedics, LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
3
Basic Information
- Brand Name
- CURVTEK EYE NEEDLE
- Primary DI
- 00880304408241
- Version / Model
- 906768
- Catalog Number
- 906768
- Company Name
- Biomet Orthopedics, LLC
- Labeler DUNS
- 129278169
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 3
- Record Status
- Published
- Publish Date
- 2020-05-20
- Public Version
- 1
- Public Version Date
- 2020-05-28
- Public Version Status
- New
- Public Device Record Key
- 66fb6350-9b09-4d09-b297-933fdc81d339
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HSZ | Instrument, surgical, orthopedic, pneumatic powered & accessory/attachment | General, Plastic Surgery | 878.4820 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44505 | Multi-purpose surgical power tool system, pneumatic | An assembly of devices designed to resect bones and tough tissues (e.g., cartilage, ligaments) during a surgical procedure; it is not dedicated to a specific clinical application. It includes a pneumatically-powered control unit which controls output of nitrogen (N2) or surgical-grade air via a connecting hose, motors/handpieces/power tool attachments, and a variety of tools (e.g., drill bits, saw blades, burs, milling cutters, shavers, screwdriver bits, guide wires). | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 70880304408240 | GS1 | ||||
| Primary | 00880304408241 | GS1 |
Customer Contacts
- Phone
- +1(800)348-9500
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 22MM X-LARGE |